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This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function.
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extra-Corporal Life Support (ECLS) | Active Comparator | Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction. |
|
| Standard treatment | No Intervention | Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-Corporal Life Support (ECLS) | Device | Extra-Corporal Life Support (ECLS) (from Sorin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) on day 30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30 days | |
| Lactate levels | up to 48 hours | |
| potentia hydrogenic levels |
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Inclusion Criteria:
Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
intended revascularization (PCI or CABG)
Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
Signs of left heart insufficiency and pulmonary congestion
Signs of impaired organ perfusion with at least one of the following:
Informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Brunner, MD | Munich University Hospital | Principal Investigator |
| Steffen Massberg, MD | Munich University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Munich | Munich | Bavaria | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31072581 | Derived | Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available. |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
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| 48 hours |
| Length of mechanical ventilation | 30 days |
| Long-term mortality at 12 months | up to 12 months |
| Length of ICU stay | 30 days |
| Neurological Outcome (modified Rankin Scale) | up to 12 months |
| MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI) | up to 12 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |